MIRA says ketamine-based drug beats current pain treatments in study | How to order Skittles Moonrock online

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MIRA Pharmaceuticals Inc. (NASDAQ: MIRA) said its experimental ketamine-based drug outperformed currently available pain treatments in preclinical studies, building on months of research that show why the compound might succeed where other treatments have failed.

The drug, known as Ketamir-2, demonstrated up to 112% more effective results than pregabalin (Lyrica) and 70% greater relief than gabapentin (Neurontin) at higher doses, the Miami-based company said Monday. The findings follow an August breakthrough where the compound achieved complete reversal of neuropathic pain in animal studies.

“Ketamir-2, a non-opioid, offers tremendous promise for patients seeking better solutions for neuropathic pain without the habit-forming risks or debilitating side effects associated with existing medications,” Erez Aminov, chairman and CEO of MIRA Pharmaceuticals, said in Monday’s statement.

The comparative results cap several months of scientific developments for MIRA. In July, researchers discovered the compound isn’t affected by a key protein that typically pumps drugs out of the brain, potentially allowing for better absorption than traditional ketamine. The following month, the company identified that the drug’s principal metabolite, called Nor-Ketamir-2, achieves nearly 100% oral bioavailability with an extended therapeutic window.

“Traditional ketamine’s limitations, including its low oral bioavailability and extensive receptor interactions, have hindered its widespread use,” Dr. Itzchak Angel, MIRA’s chief scientific advisor, said in an August statement. The company’s findings at the time suggested “a potentially safer and more effective treatment that could be administered at home.”

The research will be presented at the Annual Pain Therapeutics Summit in Boston later this month.

The development push comes as MIRA tries to stay afloat. The company reported using approximately $1.9 million in operating activities during the first half of 2024, leaving it with $2.8 million in cash as of June 30, according to SEC filings. In August, MIRA entered into an At The Market offering agreement to sell up to $19.3 million in common stock.

MIRA is targeting a neuropathic pain treatment market that’s projected to reach $5.2 billion across the U.S., Canada and Mexico by 2030. Within that space, gabapentin alone is expected to reach $4.95 billion by 2033.

Current treatments often come with significant drawbacks. Gabapentin can cause drowsiness and cognitive impairment, while pregabalin carries risks of dependence and withdrawal symptoms, according to company statements.

The U.S. Drug Enforcement Administration also previously determined that the compound would not be classified as a controlled substance, which could simplify its path to market.

“What sets Ketamir-2 apart from other current neuropathic pain treatments is its unique profile: It is not an opioid, does not share the dependency risks associated with opioids, and is classified as a non-controlled substance,” the company noted in a previous statement.

MIRA plans to file an Investigational New Drug application with the FDA by December, with human trials expected to begin in early 2025.

Beyond pain management, MIRA is also exploring Ketamir-2’s potential use in treating post-traumatic stress disorder (PTSD) and is pursuing government grants to speed development for additional neuropsychiatric conditions.

MIRA is also advancing MIRA-55, a pharmaceutical marijuana analog, for treating anxiety and cognitive decline. In July, the company reported that MIRA-55 demonstrated “higher efficacy at both the CB1 and CB2 cannabinoid receptors compared to THC” in preclinical studies.

The company went public in August 2023, raising $9 million through an IPO priced at $7 per share. The stock has since fallen to around $1.05, giving MIRA a market value of approximately $17 million.